A well-established international medical device manufacturer with a strong reputation in diagnostic and clinical solutions used across healthcare environments globally. The company operates within a highly regulated environment with a strong quality culture and collaborative cross-functional structure across Regulatory Affairs, Quality, R&D, and Clinical teams.
This role reports to the Head of QA/RA and is responsible for the creation, maintenance, and quality assurance of regulatory and technical documentation for medical devices. You will support compliant product documentation across the full lifecycle, ensuring documentation is scientifically accurate, clearly structured, and aligned with EU MDR and FDA requirements.
The position works closely with Regulatory Affairs, Quality Management, Clinical Affairs, and Development teams and will support activities including IFUs, technical files, scientific documentation, audits, and regulatory projects such as MDR transitions and change control activities.
Experience in writing technical documentation within medical devices or regulated healthcare environments
Fluent in German and English